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VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate

Primary Purpose

Over-Active Bladder

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Solifenacin succinate

Placebo

About this trial

This is an interventional treatment trial for Over-Active Bladder focused on measuring Urination Disorder, Overactive Bladder, Prostate Cancer Radiation, Vesicare

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per HIPAA Authorization for the USA test sites is obtained from subject or legally authorized representative prior to the initiation of this study (including withdrawal of prohibited medication, if applicable)
Subject must be an ambulatory male at least 18 years of age.
Subject has been diagnosed with prostate carcinoma and has elected to undergo external beam radiation therapy.
Subject is willing to complete the American Urology Association Symptom Score (AUASS) Questionnaire.

Exclusion Criteria:

Subject has undergone a prostatectomy
Subject exhibits symptoms of urinary tract infection.
Subject exhibits severe neurologic damage or has undergone prostatectomy.
Subject diagnosed with OAB and is being treated with medication for alleviation of OAB symptoms within 12 months prior to the Screening Visit.
Subject has evidence of uncontrolled narrow angle glaucoma, urinary or gastric retention, neurogenic bladder; prostatitis, or persistent UTI.
Subject exhibits hypersensitivity to Solifenacin succinate, any ingredients, or other anticholinergic agents.
Subject has undergone treatment with any investigational drug within 30 days prior to screening procedure.
Subject has exhibited history of diagnosed gastrointestinal obstructive disease.
Subjects with co-morbid lower urinary tract symptoms (LUTS).
Subjects exhibiting clinically significant bladder outflow obstruction (BOO).
In the opinion of the Study Investigator, the patient has exhibited prior to the screening or Baseline visit, a clinically significant disease or medical condition that would exclude the subject from participating in the study.
Subjects who have received prior pelvic radiation.
Subjects with history of severe hepatic impairment.
Subjects with history of Congenital or Acquired QT prolongation.

Sites / Locations

Century Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

solifenacin succinate

Placebo

Arm Description

Solifenacin succinate, 5mg or 10 mg once daily

Drug: Placebo oral

Outcomes

Primary Outcome Measures

Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).

The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score.

Secondary Outcome Measures

Full Information

NCT ID

NCT01777217

First Posted

January 24, 2013

Last Updated

January 8, 2015

Sponsor

Advanced Research Network

Collaborators

Astellas Pharma US, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01777217

Brief Title

VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate

Official Title

A Pilot Study to Assess the Safety and Efficacy of Solifenacin (VESIcare) for Improving Urinary and Bladder Functions in Patients Undergoing Radiation Therapy of the Prostate

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Terminated

Why Stopped

Terminated

Study Start Date

February 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Advanced Research Network

Collaborators

Astellas Pharma US, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if Vesicare (Solifenacin succinate) is effective in treating over-active bladder symptoms during radiation therapy of the prostate.

Detailed Description

This is a randomized double blind placebo controlled flexible dose 12 week study. Following screening, subjects will receive their first dose of study medication following completion of AUASS questionnaire on the first day of radiation treatment (baseline) and will continue for twelve weeks. Subjects will be started on 5 mg of study medication. The AUASS will be completed at baseline, weeks 4, 8 and 12. A 16 week visit conducted over a phone interview.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Over-Active Bladder

Keywords

Urination Disorder, Overactive Bladder, Prostate Cancer Radiation, Vesicare

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

solifenacin succinate

Arm Type

Active Comparator

Arm Description

Solifenacin succinate, 5mg or 10 mg once daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Drug: Placebo oral

Intervention Type

Drug

Intervention Name(s)

Solifenacin succinate

Other Intervention Name(s)

VESIcare

Intervention Description

IGRT with VESIcare

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Control

Intervention Description

IGRT with placebo

Primary Outcome Measure Information:

Title

Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).

Description

The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score.

Time Frame

baseline and 16 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per HIPAA Authorization for the USA test sites is obtained from subject or legally authorized representative prior to the initiation of this study (including withdrawal of prohibited medication, if applicable) Subject must be an ambulatory male at least 18 years of age. Subject has been diagnosed with prostate carcinoma and has elected to undergo external beam radiation therapy. Subject is willing to complete the American Urology Association Symptom Score (AUASS) Questionnaire. Exclusion Criteria: Subject has undergone a prostatectomy Subject exhibits symptoms of urinary tract infection. Subject exhibits severe neurologic damage or has undergone prostatectomy. Subject diagnosed with OAB and is being treated with medication for alleviation of OAB symptoms within 12 months prior to the Screening Visit. Subject has evidence of uncontrolled narrow angle glaucoma, urinary or gastric retention, neurogenic bladder; prostatitis, or persistent UTI. Subject exhibits hypersensitivity to Solifenacin succinate, any ingredients, or other anticholinergic agents. Subject has undergone treatment with any investigational drug within 30 days prior to screening procedure. Subject has exhibited history of diagnosed gastrointestinal obstructive disease. Subjects with co-morbid lower urinary tract symptoms (LUTS). Subjects exhibiting clinically significant bladder outflow obstruction (BOO). In the opinion of the Study Investigator, the patient has exhibited prior to the screening or Baseline visit, a clinically significant disease or medical condition that would exclude the subject from participating in the study. Subjects who have received prior pelvic radiation. Subjects with history of severe hepatic impairment. Subjects with history of Congenital or Acquired QT prolongation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sanjay Mehta, M.D.

Organizational Affiliation

Century Cancer Centers

Official's Role

Principal Investigator

Facility Information:

Facility Name

Century Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77025

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17765406

Citation

Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):67-74. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31.

Results Reference

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PubMed Identifier

12122494

Citation

Ikeda K, Kobayashi S, Suzuki M, Miyata K, Takeuchi M, Yamada T, Honda K. M(3) receptor antagonism by the novel antimuscarinic agent solifenacin in the urinary bladder and salivary gland. Naunyn Schmiedebergs Arch Pharmacol. 2002 Aug;366(2):97-103. doi: 10.1007/s00210-002-0554-x. Epub 2002 Jun 14.

Results Reference

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PubMed Identifier

10661346

Citation

Michalski JM, Purdy JA, Winter K, Roach M 3rd, Vijayakumar S, Sandler HM, Markoe AM, Ritter MA, Russell KJ, Sailer S, Harms WB, Perez CA, Wilder RB, Hanks GE, Cox JD. Preliminary report of toxicity following 3D radiation therapy for prostate cancer on 3DOG/RTOG 9406. Int J Radiat Oncol Biol Phys. 2000 Jan 15;46(2):391-402. doi: 10.1016/s0360-3016(99)00443-5.

Results Reference

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PubMed Identifier

16648499

Citation

Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006 May 1;24(13):1990-6. doi: 10.1200/JCO.2005.05.2530.

Results Reference

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PubMed Identifier

18280056

Citation

Zelefsky MJ, Yamada Y, Fuks Z, Zhang Z, Hunt M, Cahlon O, Park J, Shippy A. Long-term results of conformal radiotherapy for prostate cancer: impact of dose escalation on biochemical tumor control and distant metastases-free survival outcomes. Int J Radiat Oncol Biol Phys. 2008 Jul 15;71(4):1028-33. doi: 10.1016/j.ijrobp.2007.11.066. Epub 2008 Feb 14.

Results Reference

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PubMed Identifier

16160131

Citation

Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233. Erratum In: JAMA. 2008 Feb 27;299(8):899-900.

Results Reference

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PubMed Identifier

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Citation

Bostwick DG, Burke HB, Djakiew D, Euling S, Ho SM, Landolph J, Morrison H, Sonawane B, Shifflett T, Waters DJ, Timms B. Human prostate cancer risk factors. Cancer. 2004 Nov 15;101(10 Suppl):2371-490. doi: 10.1002/cncr.20408.

Results Reference

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VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate

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